At the intersection of these pieces is the clinic “treatment” consisting of fat stem cells (being manufactured as in a screenshot at right from a clinic YouTube video), a product the FDA has indicated is most often going to be a biological drug requiring pre-market approval, which the clinics generally do not have.

The newest newspaper article comes from The Washington Post. Laura McGinley and William Wan take a close look at stem cell clinics including especially one in Georgia, the large group it belongs to called Cell Surgical Network, the recent Grassley letter, and US Stem Cell, Inc. (and its sub-business US Stem Cell Clinic). The title of the WaPo piece gives a reader the immediate sense this is not the kind of media coverage that unproven stem cell clinic firms probably want: “Miracle cures or modern quackery? Stem cell clinics multiply, with heartbreaking results for some patients.”

Michael Hiltzik of The LA Times also has a new piece on stem cell clinics, more squarely focused on US Stem Cell and its leader, Kristin Comella. It is entitled, “Patient lawsuits, federal investigations and a ‘virtual’ PhD: Inside a would-be stem cell empire”.

As to the reference to the doctoral degree, Hiltzik writes:

“The field also strives to adopt a veneer of scientific legitimacy. Consider Comella’s stem cell biology doctorate. It was issued by the Panama College of Cell Science, which identifies itself as a nonaccredited “virtual university.” The Republic of Panama-based college offers a three-year online PhD at a price of $2,950 a year — $2,700 if paid in advance. The college calls its program “the hottest, most powerful biology graduate program in the world.”

I’ve written before over the years about US Stem Cell on this blog so there is quite a bit of background at that link. However, Hiltzik’s piece provides some additional new perspectives and info such as on the degree above and the reported ongoing plans for the business to spread across the country via a specific investment firm:

“The expansion of the company’s clinic network is being done through an outside investment firm, General American Capital Partners, which hired Comella, U.S. Stem Cell’s chief scientific officer, and Michael Tomas, its chief executive, to act in the same capacity in the rollout of American Stem Cell Centers of Excellence, the brand name of the proposed clinics. U.S. Stem Cell says the investors have committed to spend $2.5 million to open the 10 clinics.”

Finally, Ron Hurtibise at Florida’s Sun Sentinel also has a new piece on unproven clinics including US Stem Cell. It focuses on a few fronts including in particular on the Grassley letter last week to HHS/FDA. The federal agencies were requested to reply to Grassley by last Friday.

As far as I can see on the web at least there hasn’t been a reply, but according to the Sun Sentinel, “FDA spokeswoman Tara Rabin said by email Thursday that the agency plans to respond to Grassley’s letter.” Maybe there was a reply but it is confidential or the reply is coming soon.

The Sun Sentinel also asked his office about why Grassley got interested in this stem cell situation, which had been a topic of discussion in the comments on my blog post on the Senator’s letter:

“Asked why the senator took an interest in the issue, the aide responded, “Sen. Grassley has a long record of conducting vigorous oversight. In this case, he wants to make sure the FDA is properly overseeing matters within its jurisdiction and holding alleged wrongdoing to account.”

Grassley doesn’t seem like someone who’s magnifying glass you want to be under. Many are curious about what the FDA will say in reply and most importantly what if anything the agency will do on the stem cell clinic front.

Hang onto your hats as the next couple months could see some big developments.

2 Comments

Perhaps a more fitting article would be on Senator Grassley. The question was posed to his office “why Grassley got interested in this stem cell situation”? Senator Grassley’s office did not disclose who brought this matter to his attention. That is a key question, especially knowing that the Senator sure seems to promote the use of highly addictive opioids. The Senator moved S.483 – 114th Congress (2015-2016 through his Senate Judiciary Committee and subsequently the “Ensuring Patient Access and Effective Drug Enforcement Act of 2016” was signed into law. The consequences of the bill is that the DEA finds it nearly impossible to stop pharmaceutical companies from illegally supplying opioid drugs to millions of people who find themselves addicted to these drugs. Note: Big Pharma receives billions and billions of dollars by feeding America’s addiction to these prescription drugs. According to Opensecrets.org Senator Grassley has a personal net worth in excess of $3 million dollars, has raised over $35 million in campaign contributions over $3 million of which came from the medical industry. It has been stated that “Chuck Grassley, also rank in the top 10 in their dependence on health care lobbying money.” In my opinion, the folks in Iowa and in the United States of America deserve a better representative in Washington, not one that appears to be bought off by Big Pharma. per an article published by CNN on December 21, 2017, “in 2016 alone, 42,249 US drug fatalities — 66% of the total — involved opioids, the report says. That’s over a thousand more than the 41,070 Americans who die from breast cancer every year. WOW. I don’t see the Senator trying to correct his mistake, if he even thinks it was a mistake. Senator Grassley, I ask that you focus your attention on the Opioid crisis that is killing tens of thousands of American each year.